Quality Associate - Remote

Overview

This is a unique and exciting opportunity to join a growing team of passionate professionals at the forefront of cell therapy and cornea care innovation. As a Quality Associate, you will play a critical role in accomplishing this mission and in staging Aurion Biotech novel cell therapy treatment for successful launch in the United States.

In Short

• Review executed batch records
• Support Drug Product disposition activities
• Author and review Standard Operating Procedures (SOPs)
• Maintain lot files
• Support vendor management activities
• Support computer system validation activities
• Support Quality performance/continuous improvement activities
• Assist in compiling metrics for Quality Management Review
• Other duties as assigned.

Requirements

• Bachelor’s degree in Biology, Chemistry or other relevant scientific discipline preferred.
• Preferred one (1) year of full-time cGMP Quality Assurance experience.
• Experience with eQMS (e.g., ACE, TrackWise)
• Knowledge of computer system validation
• Working knowledge of current industry practices and standards in an FDA-regulated biotechnology company
• Good understanding of batch disposition principles
• Excellent record keeping and documentation skills
• Proficient use of MS Office products
• Ability to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and a great sense of urgency while ensuring that all cGMP and Regulatory requirements are met
• Ability to work effectively both independently and with other team members

Benefits

• Robust Benefits: Full health insurance for employees and families, 401(k) matching, EAP, FSA, and generous PTO.
• Total Rewards: Competitive compensation packages.
• Perks and Fun: Paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects.